Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Chronic rhinosinusitis with nasal polyps (CRSwNP)

Initial treatment

Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP; AND

Patient must have a diagnosis of CRSwNP confirmed by at least one of: (i) nasal endoscopy, (ii) computed tomography (CT) scan, with the results documented in the patient's medical records; or

Patient must have a diagnosis of CRSwNP from at least two physicians of the above mentioned prescriber types; AND

Patient must have undergone surgery for the removal of nasal polyps; or

Patient must have the written advice from at least two physicians of the above mentioned prescriber types demonstrating inappropriateness for surgery; AND

Patient must have, despite optimised nasal polyp therapy, at least two of: (i) bilateral endoscopic nasal polyp score of at least 5 (out of a maximum score of 8, with a minimum score of 2 in each nasal cavity), (ii) nasal obstruction visual analogue scale (VAS) score greater than 5 (out of a maximum score of 10), (iii) overall symptom VAS score greater than 7 (out of a maximum score of 10); AND

Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; or

Patient must have had a 12 month break in PBS-subsidised treatment with a biological medicine for this condition; AND

The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND

Patient must have failed to achieve adequate control with optimised nasal polyp therapy which has been documented; AND

Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; AND

Patient must be at least 18 years of age.

Optimised nasal polyp therapy includes:

(a) adherence to intranasal corticosteroid therapy for at least 2 months, unless contraindicated or not tolerated

(b) if required, nasal irrigation with saline

Where the patient has a contraindication or intolerance to intranasal corticosteroid therapy, document the reasons for the contraindication or intolerance in the patient's medical file.

The authority application must be made in writing and must include:

(a) details of the proposed prescription,

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice),

(c) details (date of commencement and duration of therapy) of prior optimised nasal polyp medicine treatment,

(d) details (date and treatment) of nasal polyp surgery; or

(e) if applicable, details of surgical exception including serious comorbid disease (e.g. cardiovascular, stroke) making the risk of surgery unacceptable,

(f) the eosinophil count and date,

(g) two of the following, measured within the past 12 months: (i) baseline bilateral endoscopic nasal polyp score, (ii) baseline nasal obstruction VAS score, (iii) baseline overall VAS score.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Chronic rhinosinusitis with nasal polyps (CRSwNP)

Continuing treatment

Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have both demonstrated and sustained an adequate response to this drug, defined as having at least one of: (i) an improvement in bilateral endoscopic nasal polyp score of at least 1.0 compared to the baseline level provided with the initial authority application, (ii) an improvement in nasal obstruction visual analogue scale (VAS) score of at least 3.0 compared to the baseline level provided with the initial authority application, (iii) an improvement in overall symptom VAS score of at least 2.5 compared to the baseline level provided with the initial authority application; AND

Patient must be at least 18 years of age.